NCT01461070

Brief Summary

Background: \- Some bacteria found in the large and small intestines help keep people healthy and aid digestion. They may also affect a person s risk of developing cancer. Researchers want to study the relationship between intestinal bacteria and breast cancer risk factors. They can do this by looking at stool and urine samples from postmenopausal women. Objectives: \- To study intestinal bacteria and its relationship to urine-based markers of breast cancer risk in women. Eligibility: \- Women between 55 and 69 years of age with a recent mammogram that showed no signs of cancer. Design:

  • Participants will be screened with a medical history and basic health questionnaire.
  • At home, participants will complete questionnaires about cancer risk factors and food consumption.
  • Participants will also collect urine and stool samples. They will send the samples to the designated labs for study.
  • No treatment will be provided as part of this protocol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 27, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

2.9 years

First QC Date

October 6, 2011

Last Update Submit

May 22, 2020

Conditions

Breast Neoplasms

Keywords

Breast CancerPost Menopausal EstrogensFecal Microbes

Outcome Measures

Primary Outcomes (1)

  • Breast cancer association

    breast cancer association

    cross-sectional

Secondary Outcomes (1)

  • Fecal microbiome-systemic estrogen association

    cross-sectional

Study Arms (2)

Breast Cancer Cases

Breast Cancer Cases

Controls

Controls

Eligibility Criteria

Age50 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Examining fecal microbiota in women with breast cancer

You may qualify if:

  • Female members of Kaiser Permanente Colorado (KPCO) with a recent normal mammogram who gets into a random sample of the very large population.

You may not qualify if:

  • History of cancer, except non-melanoma skin cancer
  • History of inflammatory bowel disease or diverticulitis
  • History of gastric banding or by-pass surgery
  • History of other gastric or intestinal surgery within the previous 6 months
  • Hormone prescription within the previous 12 months
  • Antibiotic prescription within the previous 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Colorado

Denver, Colorado, United States

Location

Related Publications (3)

  • Fuhrman BJ, Feigelson HS, Flores R, Gail MH, Xu X, Ravel J, Goedert JJ. Associations of the fecal microbiome with urinary estrogens and estrogen metabolites in postmenopausal women. J Clin Endocrinol Metab. 2014 Dec;99(12):4632-40. doi: 10.1210/jc.2014-2222.

    PMID: 25211668BACKGROUND

  • Feigelson HS, Bischoff K, Ardini MA, Ravel J, Gail MH, Flores R, Goedert JJ. Feasibility of self-collection of fecal specimens by randomly sampled women for health-related studies of the gut microbiome. BMC Res Notes. 2014 Apr 1;7:204. doi: 10.1186/1756-0500-7-204.

    PMID: 24690120BACKGROUND

  • Goedert JJ, Jones G, Hua X, Xu X, Yu G, Flores R, Falk RT, Gail MH, Shi J, Ravel J, Feigelson HS. Investigation of the association between the fecal microbiota and breast cancer in postmenopausal women: a population-based case-control pilot study. J Natl Cancer Inst. 2015 Jun 1;107(8):djv147. doi: 10.1093/jnci/djv147. Print 2015 Aug.

    PMID: 26032724BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Feces and urine.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Rashmi Sinha, Ph.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2011

First Posted

October 27, 2011

Study Start

August 10, 2011

Primary Completion

June 30, 2014

Study Completion

May 22, 2020

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations

US(1)